UMIN-CTR Clinical Trial

Basic information
Public title	Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Acronym	IMRT-TBI study
Scientific Title	Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Scientific Title:Acronym	IMRT-TBI study
Region	Japan

Condition
Condition	hematopoietic malignancy
Classification by specialty	Hematology and clinical oncology Pediatrics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess safety and efficacy of total body irradiation by intensity-modulated radiation therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Frequency of grade 3 or worse adverse events, based on CTCAE ver. 4.0, from 3 months to 1 year after total body irradiation.
Key secondary outcomes	Reccurence-free survial, overall survival, graft survival rate, time to graft survival, and frequency of grade 3 or worse adverse events in full observation period.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	In our institution, total body irradiation are performed as preparative regimen for hematopoietic stem cell transplantation by intensity-modulated radiation therapy. Prescribed dose is 12 Gy in 6 fractions in 3 days. Dose to lung is reduced under 10 Gy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Undergoing hematopoietic stem cell transplantation by myeloablative preparation. Performance status is from 0 to 2. With informed consent. If the patient is underage, we obtain informed consent from parent or legal representation.
Key exclusion criteria	With serious complication. With simultaneous double cancer or heterochronic double cancer in last 5 years. With previous history of radiation. Not being able to remain at rest during treatment. With technical problem for intensity-modulated radiation therapy. Being in pregnancy. Judging inadequate by any medical, psychological or other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hideomi Middle name Last name YAMASHITA
Organization	The University of Tokyo Hospital
Division name	The department of Radiology
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8667
Email	yamachan07291973@yahoo.co.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name TAKENAKA
Organization	The University of Tokyo Hospital
Division name	The department of Radiology
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8667
Homepage URL
Email	rtakenaka-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo Hospital
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-5800-5411
Email	IRBjimu-tokyo@umin.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 14 Day

Related information
URL releasing protocol	http://www.u-tokyo-rad.jp/data/IMRT-TBIprotocol.pdf
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 13 Day
Date of IRB	2015 Year 05 Month 13 Day
Anticipated trial start date	2015 Year 05 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 14 Day
Last modified on	2021 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020341